Date Initiated by Firm |
November 14, 2003 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on October 24, 2008 |
Recall Number |
Z-0185-04 |
Recall Event ID |
27691 |
510(K)Number |
k861323
|
Product Classification |
Tubes, Gastrointestinal (And Accessories) - Product Code KNT
|
Product |
Ross 14 FR Gastrostomy Tube, Item #152. |
Code Information |
Lot Numbers: 03590GZ00, 91083GZ00, 92185GZ00, 95422GZ00 |
Recalling Firm/ Manufacturer |
Ross Products Division, Abbott Laboratories 625 Cleveland Ave Columbus OH 43215-1754
|
For Additional Information Contact |
Mr. Randal P. McKay 614-624-3688
|
Manufacturer Reason for Recall |
An increase in reported balloon failures, which may result in tube displacement.
|
FDA Determined Cause 2 |
Other |
Action |
The firm notified their customers on 11/14/2003 by telephone, fax, and FedEx. Product will be returned. |
Distribution |
Nationwide. Worldwide. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = KNT and Original Applicant = MICROVASIVE
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